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Remote Assessment and Intervention for Behavior Problems in Kids With TSC

CompletedNA

Sponsor: University of California, Los Angeles

Conditions: Tuberous Sclerosis

Interventions: Parent-Child Interaction Therapy (PCIT)

Countries: United States

The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems.

Eligibility overview

Sex: ALL

Age: 3 Years to 6 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

For assessment visit:

* Clinical diagnosis of TSC
* Chronological age of 3 years, 0 months to 6 years, 11 months old at enrollment.
* English or Spanish as primary language in the home.

For intervention study only:

* Elevated behavior problems
* Parent/caregiver available to participate in PCIT

Exclusion Criteria:

For assessment visit:

* None

For intervention study:

* Plan for epilepsy surgery during study period

Locations (1)

Los Angeles, California, United States